- Provide oversight and guidance internally and externally to enable acquisition and ingestion of high quality clinical and omic datasets into Mirador360TM, ensuring compliance with established protocols and adherence to agreed timelines.
- Oversee outsourced data management activities and vendors; manage day-to-day relationship; monitor costs and quality to identify and recommend improvements.
- Ensure data within Mirador360 remains compliant with data privacy policies, patient consent, and research
- Coordinate the timely and accurate status reporting of biospecimen samples and datasets.
- Work with data architects and scientists to design and build software solutions to facilitate data access and analysis, including genomic and clinical datasets.
Biospecimen Management- Develop processes to oversee and manage the pipeline of sample requests, handling, analysis, and delivery, ensuring compliance with quality and ethical standards, as well as adherence to agreed delivery timelines.
- Maintain data platforms enabling accessioning and reconciliation of physical biospecimens and corresponding metadata (e.g., LIMS)
- Provide strategic oversight and guidance internally and externally in the areas of biospecimen sample collection, accessioning, processing, labeling, storing, and cataloging, ensuring compliance with regulations and established protocols.
- Identify, engage, and oversee vendors/partners responsible for biospecimen storage, shipping, and analysis; oversee biospecimen transfer between partners and vendors.
- Aid in biospecimen study feasibility assessments, serving as a biospecimen expert and demonstrating thorough knowledge of pharma regulatory and compliance programs.
- Work alongside clinical partners to plan and execute studies involving collection or use of biospecimens. Assist in the creation of biospecimen collection site requirements, lab manuals, site trainings, site communications and collection kits.
Qualifications- Bachelor's degree in biological sciences or related field preferred
- 8 years or more of experience in pharma, complex medical, public health, CRO, or similar research environment and at least 2 or more years of managing internal teams.
- 2 years or more of experience managing vendors for key outsourced activities.
- Understanding of large data platforms and processes to ingest, maintain and obsolesce data.
- Must be able to track and manage the flow of samples and datasets.
- Thorough knowledge and/or equivalent working knowledge of central laboratory operations (kits/supplies, logistics, laboratory operations, specimen storage, data reporting and transfers, site alerts, etc.) preferred.
- Biospecimen related certifications desired (e.g. IATA certification).
- Requires a strong working knowledge of MS Office, Word, PowerPoint, Excel, project management, and data management experience preferred.
Essential Skills and Abilities- Must be able to think strategically and work both independently and as part of a team in a smaller company environment.
- Highly organized and detail-oriented, with excellent time-management skills, and the ability to manage multiple projects and deliver on tight deadlines.
- Excellent communication, verbal and written, and interpersonal skills with strong ability to interact with internal teams and partners across all levels of the organization.
- Passion for innovation and problem solving.
- Willing to travel up to 20%.
The expected base pay range for this position is $150,000 – $225,000 plus bonus, equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. This range may be modified in the future.
All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.
Apply - Oversee outsourced data management activities and vendors; manage day-to-day relationship; monitor costs and quality to identify and recommend improvements.
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Associate Director, Biospecimen and Data Management - California, United States - Mirador Therapeutics, Inc.
Description
(San Diego, CA)
Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company's Mirador360 TM precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicines for patients living with chronic immune-mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in San Diego, CA. Summary The Associate Director, Biospecimen and Data Management is an operationally focused role which is accountable for enabling the timely and successful collection and receipt of biospecimens and clinical and genomic datasets. This role will be both internally and externally focused, serving as knowledge resource and partner to clinical data and biospecimen partners, data management vendors, and internal data science users to ensure the successful accessioning and reconciliation of collected biospecimens and biospecimen data to enable downstream processes. Responsibilities Data Management
